- Knowledge and application of current safety regulations (e.g. CoSHH) as applicable to laboratory functions
- Follow the 10 rules of GMP
- Work to appropriate laboratory systems, standards and procedures, e.g., data recording, labelling, investigation and calibration procedures. Complete analytical documentation including the input of results onto the LIMS system.
- Awareness of current regulatory standards as applicable to laboratory functions.
- Maintain good laboratory housekeeping.
- Maintain GMP / GLP standards and principles within the laboratory area.
- Perform analytical testing using methods where training has been received with minimal avoidable errors in order to meet scheduled timelines.
- Perform new test methods and techniques once full training has been received.
- Complete preliminary investigations with minimum support. Complete full-scale investigations with support.
- Review and issue GMP documentation where full training has been received.
- Have a basic knowledge of pharmaceutical products and testing.
- Develop an understanding of the tests carried out and their impact on the products / materials worked on.
- Responsible for the maintenance and calibration of laboratory equipment.
- Support continuous improvement activities within own group.
- Participate as a team member for Group CI projects as appropriate.
- Develop a basic understanding of the resources required to perform laboratory-based activities.
- Ideally have worked with GLP, GMP, Specifications and Test Methods
- Ideally have 1 year of experience of testing within the Pharmaceutical Laboratory
- Ideally have hands on experience of HPLC, and UV techniques
- Ideally have knowledge of pharmaceutical testing requirements, testing equipment and current Analytical techniques.
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Laboratory Analyst - Loughborough, Leicestershire, United Kingdom - Kindeva Drug Delivery
Description
Kindeva is a global pharmaceutical contract developer and manufacturer (CDMO) business headquartered in St. Paul, MN. Kindeva was established following 3M's sale of substantially of all its drug delivery business to affiliates of Altaris Capital Partners.
Kindeva is navigating a period of dynamic change and growth as a result of the sale and business opportunities in its pipeline. Kindeva partners with global pharmaceutical companies to commercialize products, primarily through inhalation and transdermal delivery technologies.
Summary of Position
We are looking for a talented QC Laboratory Shift Technician to join our Loughborough team. Rotating between Kindeva's Investigations Team and Analytical Team, this role will be responsible for the testing of pharmaceutical raw materials (including components), intermediates and finished products for batch release, stability, development studies and customer complaints in line with site procedures. The employee would represent the department as required to include external customers and regulators.
Other responsibilities are included in the employee review process along with other tasks that may be deemed appropriate by supervision.
Job ResponsibilitiesSafety
GMP
Analytical Testing
Product, Equipment and Process Knowledge
Time Management
Please note that this is not an exhaustive list of responsibilities.
S kills & Experience
What we will give to you:
Attractive compensation package
Company pension scheme (up to 10% employer contribution)
25 days holiday per year (plus bank holidays) plus service days after 5 years
Company sick pay
Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family
Life assurance of four times life cover salary
